- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability to ... (PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Head, Global QMS (RD PV QA) and is a member of the leadership team . Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven ... and drives process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and engages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...targeted source document verification and targeted source data review. Lead the team to develop and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a team of safety ... of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions,...resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respond appropriately to these concerns, barriers, and the evolving marketplace. The role will lead the training efforts and support the needs of a variety of DSI ... Director is also responsible for gaining cross function inputs and lead the projects' execution, tactical implementation, and sustainment leading to improved… more
- Merck & Co. (Rahway, NJ)
- …Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse ... candidates from development to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in our Manufacturing Division… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation...well as programs or franchises.When sitting on a study team , lead the study team … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality ... other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document and record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies for the needs ... training across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productive work environment. This pivotal position will report directly to the Senior Director of Operations.Key Responsibilities Champion and lead the employee ... Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC ... Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse… more
- Merck & Co. (Rahway, NJ)
- …provide solutions to otherwise intractable problems faced by the business. - Our team ensures the scientific community at our company is well-positioned to rapidly ... of scientists, engineers, and IT to broadly shape and lead our identification and internalization of tools to create,...as converse at high technical level with architects and senior scientists. Expertise in data engineering, data science, Machine… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our company's Research Laboratories (is...Biologics. You will collaborate with a creative and dedicated team of scientists and engineers to design purification processes… more
- Merck & Co. (Rahway, NJ)
- …publication, and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee program strategy and ... business development assessments of external opportunities.Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to...You will collaborate with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external constituencies, develop partner relationships, and influence thinking of senior leadership members Proven leader capable of building high-performing ... and act as a strategy partner to the Executive Team (ET). Leads the USO Strategy team ,...and Global inputs, support and alignment, to focus and lead cross-functional teams toward development and execution of cross-organizational… more
- Merck & Co. (Rahway, NJ)
- …direction of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead , the Senior Scientist has responsibility for coordinating global ... Senior Scientist will work closely with the PaCES lead to collaborate with individuals from Clinical Research, Regulatory...Team (CTT) meetings on behalf of the PaCES lead to facilitate alignment of the selection of an… more
